On March 2, 2023 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of solid tumors, reported its financial results for the year ended December 31, 2022, and a pipeline update including the status of the interim analysis of for the Company’s Phase III TIGeR-PaC clinical trial (Press release, Renovorx, MAR 2, 2023, View Source [SID1234628073]).

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RenovoRx anticipates finalizing the interim analysis for the TIGeR-PaC Phase III trial and releasing the results within the next week or so. To date, 47 out of 114 target post-SBRT/chemotherapy patients have been randomized in the TIGeR-PaC clinical trial, and the Company has received reports of 26 events (deaths) in this population. This 26th event represents 30% of the 86 events and thus triggered the first planned interim analysis and a meeting of the study’s Data Monitoring Committee ("DMC") to evaluate the ongoing progression of the Phase III clinical trial. Upon completion of the analysis and assessment of the data by the DMC, and RenovoRx’s subsequent review of their findings, the Company will report the first interim analysis

TIGeR-PaC is a randomized multi-center Phase III open label clinical trial designed to investigate the Company’s first product candidate, RenovoGemTM, which utilizes RenovoRx’s proprietary therapy platform, RenovoTAMP, to provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat locally advanced pancreatic cancer (LAPC) following stereotactic body radiation therapy (SBRT). The study is comparing treatment with RenovoTAMP versus standard of care systemic intravenous (IV) administration of gemcitabine and nab-paclitaxel. The study is designed to randomize 114 patients (57 in each arm) with all patients receiving upfront induction chemotherapy and SBRT. Final analysis will be conducted after 86 protocol-specified events have occurred in the SBRT population with two planned interim analyses: the first analysis when 30% of the specified events have been reported (data announcement forthcoming) and the second analysis when 60% of the events have been reported (expected in 2024

RenovoRx has continued to grow in 2022 as we have focused on advancing our innovative therapy platform with the vision of disrupting the current standard of care," said Shaun Bagai, CEO of RenovoRx. "Over the past year, we have advanced our mission to transform oncology therapy with our TIGeR-PaC Phase III study, treating pancreatic cancer, and expanding our clinical pipeline to treat other solid tumors. We have also built a strong internal team, and we look forward to continued progress as we strive to give our patients not just more time but more quality time that they can spend with their loved ones

Fiscal Year 2022 and Subsequent Operational Highlights:

● Announced Initial Results in Pharmacokinetic Substudy at the 2023 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium: Data on RenovoGem supports potential for RenovoTAMP therapy platform to increase local gemcitabine delivery and decrease side effects of pancreatic cancer treatment

● Eighth U.S. patent issued extending the intellectual property coverage of the RenovoTAMP therapy platform

● Acceptance of four clinical data abstracts at the 2023 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium

● Presented RenovoTAMP therapy platform at the Advanced Interventional Management Symposium

● Presented at Symposium on Clinical Interventional Oncology

● Appointed Angela Gill Nelms as Chief Operating Officer

● Appointed James Ahlers as Chief Financial Officer

● Participated in University of Cambridge Academy of Therapeutic Sciences Gateway to Translation Seminar Series

● Presented preclinical research data demonstrating potential utility for treatment of bile duct cancer

● Enrolled first pancreatic cancer patient at Columbia University’s New York-Presbyterian Hospital Irving Medical Center in TIGeR-PaC clinical trial study

● Presented at 2022 SPECTRUM Conference

Financial Highlights for the Fiscal Year Ended December 31, 2022

● Cash, cash equivalents and marketable securities as of December 31, 2022, were $6.4 million. We estimate that our current capital resources will be sufficient to fund our operating expenses and capital expenditure requirements into the third quarter of 2023.

● Total assets and total liabilities as of December 31, 2022, were $7.3 million and $1.1 million, respectively.

● Total operating expenses were $10.0 million for the year ended December 31, 2022, compared to $5.7 million for the year ended December 31, 2021. The increase was related to higher research and development expenses and general and administrative expenses.

● Research and development expenses were $4.3 million for the year ended December 31, 2022, compared to $3.0 million for the year ended December 31, 2021. The increase was primarily related to higher costs for contracted research development and consulting, including employee related costs and costs associated with a secondary manufacturer for the RenovoCath delivery system. In addition, allocated general administrative support costs increased during the year.

● General and administrative expenses were $5.6 million for the year ended December 31, 2022, compared to $2.6 million for the year ended December 31, 2021. The increase was primarily related to higher professional and consulting costs, including legal expenses, employee-related costs and D&O and liability insurance and other expenses. The increase was partially offset by general and administrative support costs allocated to research and development expenses.

● Net loss was $9.9 million for the ended December 31, 2022, compared to net loss of $6.3 million for year ended December 31, 2021.

● Net loss per share, basic and diluted were ($1.09) for the year ended December 31, 2022, compared to ($1.21) for the year ended December 31, 2021.

● As of December 31, 2022 the Company had 9,097,701 common shares outstanding.